FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

70 results for "Icu Medical, Inc."
1–24 of 70
Search insights Median review: 111d Cleared: 100% Top manufacturer: Icu Medical, Inc. Lead specialty: General Hospital
Cleared Apr 02, 2026
LifeShield Infusion Safety Software Suite
K252130 · PHC
Icu Medical, Inc.
General Hospital · 269d
Cleared Mar 27, 2026
OTTO™ Disinfecting Cap
K252006 · QBP
Icu Medical, Inc.
General Hospital · 273d
Cleared Mar 20, 2026
ClaveQS™ Bag
K251980 · KPE
Icu Medical, Inc.
General Hospital · 266d
Cleared Jun 05, 2025
Clave™ Neutral-Displacement Needlefree Connectors
K250616 · FPA
Icu Medical, Inc.
General Hospital · 97d
Cleared Apr 02, 2025
LifeShield Infusion Safety Software Suite
K242117 · PHC
Icu Medical, Inc.
General Hospital · 257d
Cleared Apr 02, 2025
Plum Duo™ Precision IV Pump
K242115 · FRN
Icu Medical, Inc.
General Hospital · 257d
Cleared Apr 02, 2025
Plum Solo™ Precision IV Pump
K242114 · FRN
Icu Medical, Inc.
General Hospital · 257d
Cleared Jan 22, 2025
Rio™ Drug Reconstitution Transfer Device
K243985 · LHI
Icu Medical, Inc.
General Hospital · 30d
Cleared Aug 24, 2023
Plum Duo™ Infusion System
K223607 · FRN
Icu Medical, Inc.
General Hospital · 265d
Cleared Aug 24, 2023
LifeShield™ Infusion Safety Software Suite
K223606 · PHC
Icu Medical, Inc.
General Hospital · 265d
Cleared Aug 31, 2018
ChemoCLAVE Cytotoxic Medication Preparation and Delivery System
K173477 · ONB
Icu Medical, Inc.
General Hospital · 291d
Cleared Aug 10, 2018
Diana Medication Transfer Set
K170110 · ONB
Icu Medical, Inc.
General Hospital · 575d
Cleared May 05, 2016
Cogent Hemodynamic Monitoring System
K152006 · DXQ
Icu Medical, Inc.
Cardiovascular · 289d
Cleared Jan 19, 2016
Hospira Extension Sets
K151969 · FPA
Icu Medical, Inc.
General Hospital · 187d
Cleared Mar 04, 2015
Hospira Blood Set
K143087 · FPA
Hospira, Inc.
General Hospital · 128d
Cleared Jan 16, 2015
PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0...
K141789 · FRN
Hospira, Inc.
General Hospital · 198d
Cleared Jan 15, 2015
IV Administration
K142622 · FPA
Hospira, Inc.
General Hospital · 121d
Cleared Nov 25, 2014
Hospira Primary Sets
K142367 · FPA
Hospira, Inc.
General Hospital · 92d
Cleared Jul 02, 2014
PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY...
K140129 · DQE
Icu Medical, Inc.
Cardiovascular · 167d
Cleared Jul 26, 2013
CHEMOLOCK, CHEMOLOCK PORT
K131549 · ONB
Icu Medical, Inc.
General Hospital · 58d
Cleared Dec 17, 2010
HIGH PRESSURE SETS-400 PSI
K100576 · FPA
Icu Medical, Inc.
General Hospital · 291d
Cleared Jul 09, 2010
CLAVE NEUTRON
K100434 · FPA
Icu Medical, Inc.
General Hospital · 143d
Cleared Apr 10, 2009
ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE
K090189 · FPA
Icu Medical, Inc.
General Hospital · 74d
Cleared Apr 06, 2009
SPINNING SPIROS, MODEL CH-2000
K082806 · FPA
Icu Medical, Inc.
General Hospital · 194d